| Product |
Company |
Generic name |
KEGG DRUG |
|
ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) kit (NDA)
|
Fenwal, Inc. |
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution |
D08745
|
VITRAKVI capsule 25 mg (NDA)
VITRAKVI capsule 100 mg (NDA)
VITRAKVI solution 20 mg/mL (NDA)
|
Loxo Oncology, Inc. |
LAROTRECTINIB |
D11138
|
|
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED injection, suspension 5 [Lf]/.5mL (BLA)
|
Sanofi Pasteur Inc. |
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) |
D05256
|
|
Caffeine Citrate solution 20 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
CAFFEINE CITRATE |
D07603
|
Buspirone Hydrochloride tablet 5 mg (ANDA)
Buspirone Hydrochloride tablet 7.5 mg (ANDA)
Buspirone Hydrochloride tablet 10 mg (ANDA)
Buspirone Hydrochloride tablet 15 mg (ANDA)
Buspirone Hydrochloride tablet 30 mg (ANDA)
|
Epic Pharma, LLC |
Buspirone Hydrochloride |
D00702
|
|
Risperidone tablet 2 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Risperidone |
D00426
|
|
Sucralfate tablet 1 g (NDA AUTHORIZED GENERIC)
|
Aphena Pharma Solutions - Tennessee, LLC |
Sucralfate |
D00446
|
|
Verapamil Hydrochloride injection 2.5 mg/mL (ANDA)
|
Micro Labs Limited |
Verapamil Hydrochloride |
D00619
|
|
Tramadol Hydrochloride tablet, film coated 50 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Tramadol Hydrochloride |
D01355
|
|
Orabloc injection 40 mg/mL (NDA)
|
Pierrel S.p.A. |
articaine hydrochloride and epinephrine bitartrate |
D11290
|
|
LEVOFLOXACIN solution/ drops 15 mg/mL (ANDA)
|
Micro Labs Limited |
Levofloxacin |
D00588
|
|
TEMAZEPAM capsule 7.5 mg (NDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
temazepam |
D00370
|
|
simvastatin tablet, film coated 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
simvastatin |
D00434
|
|
Allopurinol tablet 300 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Allopurinol |
D00224
|
|
Lorazepam tablet .5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Lorazepam |
D00365
|
|
Zolpidem Tartrate tablet, film coated, extended release 12.5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Zolpidem Tartrate |
D00706
|
|
Zoledronic Acid injection 4 mg00mL (ANDA)
|
Gland Pharma Limited |
zoledronic Acid |
D01968
|
Tadalafil tablet, film coated 2.5 mg (ANDA)
Tadalafil tablet, film coated 5 mg (ANDA)
Tadalafil tablet, film coated 10 mg (ANDA)
Tadalafil tablet, film coated 20 mg (ANDA)
|
Camber Pharmaceuticals, Inc. |
Tadalafil |
D02008
|
|
Triamterene and Hydrochlorothiazide capsule 25 mg (ANDA)
|
Zydus Pharmaceuticals (USA) Inc. |
Triamterene and Hydrochlorothiazide |
D10269
|
|
Intralipid emulsion 20 g00mL (NDA)
|
Baxter Healthcare Corporation |
I.V. Fat Emulsion |
D04962
|
Levofloxacin injection, solution 250 mg/50mL (ANDA)
Levofloxacin injection, solution 500 mg00mL (ANDA)
Levofloxacin injection, solution 750 mg50mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Levofloxacin |
D00588
|
Levofloxacin injection, solution 250 mg/50mL (ANDA)
Levofloxacin injection, solution 500 mg00mL (ANDA)
Levofloxacin injection, solution 750 mg50mL (ANDA)
|
Hikma Pharmaceuticals USA Inc. |
Levofloxacin |
D00588
|
|
Adenosine injection, solution 3 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC |
Adenosine |
D00045
|
Metoprolol succinate tablet, extended release 100 mg (ANDA)
Metoprolol succinate tablet, extended release 200 mg (ANDA)
|
BluePoint Laboratories |
Metoprolol succinate |
D00635
|
|
ERYTHROMYCIN capsule, delayed release 250 mg (ANDA)
|
Arbor Pharmaceuticals, Inc. |
Erythromycin |
D00140
|
Fluoxetine capsule 40 mg (ANDA)
Fluoxetine capsule 20 mg (ANDA)
Fluoxetine capsule 10 mg (ANDA)
|
Bryant Ranch Prepack |
Fluoxetine Hydrochloride |
D00823
|
|
Omeprazole capsule, delayed release 40 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC |
Omeprazole |
D00455
|
TRIHEXYPHENIDYL HYDROCHLORIDE tablet 5 mg (ANDA)
TRIHEXYPHENIDYL HYDROCHLORIDE tablet 2 mg (ANDA)
|
Novitium Pharma LLC |
TRIHEXYPHENIDYL HYDROCHLORIDE |
D00787
|
|
Pyridostigmine solution 60 mg/5mL (ANDA)
|
Novitium Pharma LLC |
Pyridostigmine bromide oral |
D00487
|
|
Imatinib mesylate tablet, film coated 100 mg (ANDA)
|
Armas Pharmaceuticals Inc. |
imatinib mesylate |
D01441
|
|
Entacapone tablet, film coated 200 mg (NDA AUTHORIZED GENERIC)
|
Aphena Pharma Solutions - Tennessee, LLC |
Entacapone |
D00781
|
|
Imatinib mesylate 400 mg tablet, film coated 400 mg (ANDA)
|
Armas Pharmaceuticals Inc. |
imatinib mesylate |
D01441
|
divalproex sodium tablet, delayed release 125 mg (ANDA)
divalproex sodium tablet, delayed release 250 mg (ANDA)
divalproex sodium tablet, delayed release 500 mg (ANDA)
|
Dr.Reddy's Laboratories Limited |
divalproex sodium |
D00304
|
Carvedilol tablet, film coated 3.125 mg (ANDA)
Carvedilol tablet, film coated 6.25 mg (ANDA)
Carvedilol tablet, film coated 12.5 mg (ANDA)
Carvedilol tablet, film coated 25 mg (ANDA)
|
Dr. Reddy's Laboratories Limited |
Carvedilol |
D00255
|
Mirtazapine tablet, film coated 15 mg (ANDA)
Mirtazapine tablet, film coated 30 mg (ANDA)
|
NCS HealthCare of KY, Inc dba Vangard Labs |
Mirtazapine |
D00563
|
Zafirlukast tablet, film coated 10 mg (ANDA)
Zafirlukast tablet, film coated 20 mg (ANDA)
|
Dr. Reddys Laboratories Limited |
Zafirlukast |
D00411
|
|
Methocarbamol injection 100 mg/mL (ANDA)
|
Dr.Reddy's Laboratories Inc., |
Methocarbamol |
D00402
|
Nizatidine capsule 150 mg (ANDA)
Nizatidine capsule 300 mg (ANDA)
|
Dr Reddy's Laboratories Limited |
Nizatidine |
D00440
|
Fenofibrate capsule 43 mg (ANDA)
Fenofibrate capsule 130 mg (ANDA)
|
Dr. Reddy's Laboratories Limited |
Fenofibrate |
D00565
|
|
fenofibrate tablet 160 mg (ANDA)
|
NCS HealthCare of KY, Inc dba Vangard Labs |
fenofibrate |
D00565
|